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RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Primary Purpose

Birth Control, Contraception, Contraceptive Usage

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Additional Standardized Counseling

About this trial

This is an interventional supportive care trial for Birth Control focused on measuring Contraceptive implant, Birth control, Nexplanon

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
Ability to consent in English

Exclusion Criteria:

Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Sites / Locations

Planned Parenthood of the St. Louis Region and Southwest MissouriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care Clinician Counseling

Additional Standardized Counseling

Arm Description

Outcomes

Primary Outcome Measures

Nexplanon Discontinuation Rates

Based subjects' self-reported ability to cope with various changes in bleeding patterns, and other demographic information, we will analyze whether an association exists between those who discontinue their method use early due to troublesome bleeding and the counseling they received on the day of method insertion.

Secondary Outcome Measures

Full Information

NCT ID

NCT04558229

First Posted

September 15, 2020

Last Updated

July 11, 2022

Sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04558229

Brief Title

RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Official Title

Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 24, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Planned Parenthood of the St. Louis Region and Southwest Missouri

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Birth Control, Contraception, Contraceptive Usage, Family Planning

Keywords

Contraceptive implant, Birth control, Nexplanon

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

1:1 fashion with block sizes of 8 using a computer-generated random allocation

Masking

ParticipantCare ProviderInvestigator

Masking Description

All study team members will be blinded to the randomization, with the exception of the research member who will be delivering the counseling.

Allocation

Randomized

Enrollment

348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care Clinician Counseling

Arm Type

No Intervention

Arm Title

Additional Standardized Counseling

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Additional Standardized Counseling

Intervention Description

Research staff will follow a script designed to give unbiased, medically accurate information regarding bleeding changes that may occur with use of a contraceptive ENG implant.

Primary Outcome Measure Information:

Title

Nexplanon Discontinuation Rates

Description

Time Frame

6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Cis-gendered females; Assigned female at birth and not using hormone therapy

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits Ability to consent in English Exclusion Criteria: Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Loire Biggs

Phone

3145317526

Ext

384

loire.biggs@ppslr.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tenaya Drapkin, MSW

Phone

3145317526

Ext

362

tenaya.drapkin@ppslr.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen P McNicholas, DO, MSCI

Organizational Affiliation

Planned Parenthood of the St. Louis Region and Southwest Missouri

Official's Role

Principal Investigator

Facility Information:

Facility Name

Planned Parenthood of the St. Louis Region and Southwest Missouri

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Loire Biggs

Phone

314-531-7526

Ext

384

loire.biggs@ppslr.org

First Name & Middle Initial & Last Name & Degree

Colleen P McNicholas, DO, MSCI

12. IPD Sharing Statement

Learn more about this trial

RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

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